Evaluation of the Effectiveness of a Quality Improvement Intervention
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ClinicalTrials.gov Identifier: NCT04278612 |
Recruitment Status :
Completed
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
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Condition or disease | Intervention/treatment | Phase |
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Maternal and Child Health | Other: Quality improvement intervention to strengthen health service provision | Not Applicable |
Background: Despite policies and guidelines recommending integration of health services in South Africa, provision of maternal and child health services remains fragmented. This study evaluated a rapid, scaleable, quality improvement intervention to improve integration of maternal and child health and HIV services at a primary health level, in KwaZulu-Natal, South Africa.
Methods: A three-month intervention comprised of six quality improvement mentoring visits, learning sessions with clinic staff to share learnings, and a self-administered checklist aimed to assist health workers monitor and implement an integrated package of health services for mothers and children. The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics between December 2016-February 2017. A multi-level, mixed effects logistic regression was used to account for random cluster fixed time and group effects using Stata V13.1.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1438 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Evaluation of the Effectiveness of a Quality Improvement Intervention to Support Integration of Maternal, and Child and HIV Care in Primary Health Care Facilities in South Africa |
Actual Study Start Date : | January 18, 2016 |
Actual Primary Completion Date : | February 5, 2017 |
Actual Study Completion Date : | January 16, 2019 |

Arm | Intervention/treatment |
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Experimental: Intervention
Provision of comprehensive care including the following: Baby: Measure weight and length Plot on appropriate growth charts in Road to Health Card (RTHC) Discuss with mother about the growth of the baby Identification of malnutrition and appropriate management Age-appropriate nutrition counselling Immunisation Developmental screening Vitamin A supplementation Deworming HIV Care: If mother is HIV positive -
Mother: Cervical cancer screening Provide family planning Screening tuberculosis (TB) and sexually transmitted infections (STIs) HIV Care:
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Other: Quality improvement intervention to strengthen health service provision
Quality improvement intervention comprising of regular improvement meetings based at clinics. |
Active Comparator: Control
Routine maternal and child care service delivery
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Other: Quality improvement intervention to strengthen health service provision
Quality improvement intervention comprising of regular improvement meetings based at clinics. |
- Quality of Maternal and Child Care [ Time Frame: 3 months ]Proportion of mother-baby pairs who received comprehensive care
- Quality of Child Care [ Time Frame: 3 months ]Proportion of babies who receive growth monitoring services
- Quality of Maternal Care [ Time Frame: 3 months ]Proportion of mothers who receive feeding advice

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Women who attended the clinic for maternal and child health care services. |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Women who attended the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.
Exclusion Criteria:
Women who did not attend the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.
Responsible Party: | Christiane Horwood, Senior Researcher, University of KwaZulu |
ClinicalTrials.gov Identifier: | NCT04278612 |
Other Study ID Numbers: |
UNIP123 |
First Posted: | February 20, 2020 Key Record Dates |
Last Update Posted: | February 20, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | IPD will not be shared |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | Anytime |
Access Criteria: | We are more than happy to share our study protocol, statistical analysis plan or informed consent with anyone who is interested. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Quality improvement Integrated care Maternal health Child health HIV/AIDS |
South Africa Growth Monitoring Child Growth Nutrition |